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Home » Stryker wins FDA clearance for nerve ablation system

Stryker wins FDA clearance for nerve ablation system

May 19, 2025 By Sean Whooley

Stryker OptaBlate BVN nerve ablation system
The OptaBlate BVN nerve ablation system. [Images courtesy of Stryker]
Stryker (NYSE: SYK) announced today that it received FDA 510(k) clearance for its OptaBlate basivertebral nerve ablation system (OptaBlate BVN).

Portage, Michigan–based Stryker designed OptaBlate BVN for a targeted minimally invasive procedure. It aims to provide long-lasting vertebrogenic pain relief. Stryker says adding OptaBlate BVN to its pain portfolio expands its advanced pain therapy solutions for patients. It also lands at the intersection of two core competencies, the company says — radiofrequency (RF) ablation and vertebral access.

Dr. Jad Khalil, spine surgeon at Michigan Orthopaedic Surgeons, says OptaBlate BVN could address the limitations of current treatments. According to Khalil, patients with chronic low back pain try treatments like physical therapy, injections and medications. However, they fail to see lasting relief.

“BVNA is a minimally invasive and innovative procedure that targets a key source of this pain, particularly in patients with specific MRI findings,” Khalil said. “Before BVNA, options for lasting relief were limited. For many, it offers meaningful improvement and can help avoid more aggressive treatments like surgery.”

According to Stryker, the system can ablate at least a 1 cm lesion in seven minutes. It features a steerable, dynamic curved introducer for targeted performance. The system, which has 10-gauge access tools, also has microinfusion technology. This keeps the zone hydrated, reducing impedance errors and preventing charring.

“We have a long history in radiofrequency ablation, and we’re relentlessly committed to delivering groundbreaking approaches to protect and promote quality of life,” said Kristen Berg, VP and GM of Stryker’s Interventional Spine business. “Our legacy providing solutions to reduce pain now continues with OptaBlate BVN, addressing the underserved population suffering from chronic vertebrogenic lumbar pain.”

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Orthopedics, Radiosurgery/Radiation therapy, Regulatory/Compliance, Spine Tagged With: FDA, Stryker

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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